Ceglar

Patient Information Leaflet

Ceglar, 450 mg, film-coated tablets
Valganciclovir
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet Contents

1. What Ceglar is and what it is used for
2. Important information before taking Ceglar
3. How to take Ceglar
4. Possible side effects
5. How to store Ceglar
6. Contents of the pack and other information

1. What Ceglar is and what it is used for

Ceglar belongs to a group of medicines that work by directly preventing the replication of viruses. The active substance in Ceglar, valganciclovir, is converted in the body to ganciclovir. Ganciclovir prevents the cytomegalovirus (CMV) from multiplying and infecting healthy cells in the body. In patients with weakened immune systems, cytomegalovirus may cause infections in various organs, which can be life-threatening.

Ceglar is used:

• To treat CMV retinitis (inflammation of the retina of the eye) in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the retina may lead to visual disturbances and even loss of vision.
• To prevent CMV infection in adult and pediatric patients who are CMV-negative and who have received an organ transplant from a CMV-positive donor.

2. Important information before using Ceglar

When not to use Ceglar
if the patient is allergic to valganciclovir, ganciclovir, or to any of the other
components of this medicine (listed in section 6);
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Ceglar, discuss with your doctor or pharmacist if:
the patient is allergic to acyclovir, penciclovir, valacyclovir, or famciclovir—other medicines
used in the treatment of viral infections.

Exercise special caution while using Ceglar if:
the patient has a low number of white blood cells, red blood cells, or platelets (small blood cells involved in the blood clotting process); the doctor will recommend blood tests before starting Ceglar treatment and additional blood tests during treatment;
if the patient is undergoing radiotherapy or hemodialysis;
if the patient has impaired kidney function; the doctor may prescribe a reduced dose of the medicine and recommend regular blood tests during treatment;
if the patient is currently taking ganciclovir capsules and the doctor has decided to switch to Ceglar tablets. It is important not to take more tablets than prescribed by the doctor, as this may lead to overdose.

Ceglar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Ceglar with food and drink
Ceglar should be taken during a meal. If the patient is unable to eat for any reason, they should
nevertheless take the prescribed dose of Ceglar.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before taking this medicine.

Women who are pregnant should not use Ceglar unless advised by a doctor. If the patient is
pregnant or planning a pregnancy, she must inform her doctor.

Ceglar taken during pregnancy may have harmful effects on the unborn child.

Ceglar must not be taken during breastfeeding. If a doctor recommends starting treatment
with Ceglar, breastfeeding must be discontinued before beginning therapy.

Women of childbearing potential must use effective contraception during treatment
and for at least 7 months after its completion.

Men taking Ceglar whose partners could become pregnant should use condoms during treatment
and for 4 months after its completion.

Driving and operating machinery
If the patient experiences dizziness, fatigue, tremor or confusion while taking Ceglar,
they should not drive, use tools or operate machinery.

Consult a doctor before taking any medicine.

3. How to use Ceglar

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Handle the tablets of this medicine with care; do not break or crush them.
Tablets should be swallowed whole, preferably during a meal. If you accidentally touch a damaged
tablet, wash your hands thoroughly with soap and water. If any powder from the tablet comes into
contact with the eyes, rinse the eyes immediately and thoroughly with sterile water (or clean water if
sterile water is not available).
To avoid overdose, strictly follow the number of tablets prescribed by your doctor.
If possible, Ceglar tablets should be taken with food – see section 2.
For children and adolescents who require dose adjustment, the medicine is available in another
pharmaceutical form.

Adults

Prevention of cytomegalovirus disease in transplant recipients
Treatment should be started within 10 days after transplantation.
The recommended dose is two tablets taken ONCE daily.
This dose should be continued until 100 days after transplantation. For kidney transplant recipients,
the doctor may recommend continuing treatment for 200 days.

Treatment of active CMV retinitis in patients with AIDS
(initial treatment)
The recommended dose is two tablets taken TWICE daily for 21 days (three weeks).
Do not use the medicine for longer than 21 days without medical advice, as this may increase the risk
of adverse effects.

Patients with impaired kidney function may be advised by their doctor to take a lower daily dose of tablets or to take them on specific days each week. It is very important to follow the dose of tablets prescribed by the doctor.

Patients with liver function disorders
The use of valganciclovir in patients with impaired liver function has not been studied.

Use in children and adolescents
Prevention of CMV disease in transplant recipients
Treatment in children should be started within 10 days after transplantation. The dose administered may vary depending on the child's size, and should be given ONCE daily. The doctor determines the appropriate dose based on the child's height, body weight, and kidney function. The recommended dose should be administered for 100 days. If the child received a kidney transplant, the doctor may recommend taking the medicine for 200 days.

In children who are unable to swallow Ceglar tablets, valganciclovir oral solution powder can be used instead.

Taking more Ceglar tablets than prescribed
If a patient has taken or suspects having taken more tablets than prescribed, they should contact their doctor or the nearest hospital immediately. Taking too high a dose of the medicine may cause severe adverse effects, particularly affecting the blood or kidneys. Hospital treatment may be necessary.

Missed dose of Ceglar
If a dose of the medicine is missed, it should be taken as soon as remembered, and the next dose should be taken at the usual time. A double dose must not be taken to make up for the missed dose.

Stopping Ceglar treatment
Do not stop taking this medicine without consulting your doctor.

If there are any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.
Allergic reactions
Less than 1 in 1,000 people may experience a sudden and severe allergic reaction to valganciclovir
(anaphylactic shock). If the patient develops any of the symptoms listed below, STOP using the medicine immediately and go to the nearest hospital emergency department:
raised, itchy skin rash (urticaria)
sudden swelling of the throat, face, lips, or mouth, which may cause difficulty
swallowing or breathing
sudden swelling of the hands, feet or ankles
Severe side effects
If the patient experiences any of the severe side effects listed below, seek medical advice immediately. The doctor may advise stopping treatment with Ceglar, and the patient may require urgent medical care.
Very common: may occur in more than 1 in 10 people

• low white blood cell count – symptoms include signs of infection such as sore throat, mouth ulcers, or fever
• low red blood cell count – symptoms include shortness of breath or fatigue, palpitations, or pale skin

Common: may occur in no more than 1 in 10 people

• blood infection (sepsis) – symptoms include fever, chills, palpitations, confusion, and slurred speech
• low platelet count – symptoms include easier than usual bleeding or bruising, blood in urine or stool, or bleeding gums; bleeding may be severe
• significantly reduced blood cell counts
• pancreatitis – symptom is severe abdominal pain radiating to the back
• seizures

Uncommon: may occur in no more than 1 in 100 people

• bone marrow failure (inability of the bone marrow to produce blood cells)
• hallucinations – hearing or seeing things that are not real
• abnormal thinking or feelings, loss of contact with reality
• kidney failure

The side effects listed below have been reported during treatment with valganciclovir or ganciclovir.
Other side effects
If any of the following side effects occur, inform your doctor, pharmacist, or nurse:
Very common (may occur in more than 1 in 10 people)
oral candidiasis (thrush)
upper respiratory tract infection (e.g. sinusitis, tonsillitis)
loss of appetite
headache
cough
shortness of breath
diarrhea
nausea or vomiting
abdominal pain
rash
fatigue
fever
Common (may occur in no more than 1 in 10 people)
influenza
urinary tract infection – symptoms include fever, more frequent urination, pain during urination
skin and subcutaneous tissue infection
mild allergic reaction – symptoms include redness and itching of the skin
weight loss
feeling of depression, anxiety, or confusion
difficulty sleeping
weakness or numbness in hands or feet, which may affect balance
changes in sensation such as tingling, tickling, pricking, or burning
changes in taste perception
chills
conjunctivitis, eye pain, or vision disturbances
ear pain
low blood pressure, which may cause dizziness or fainting
difficulty swallowing
constipation, gas, indigestion, stomach pain, abdominal swelling
mouth ulcers
abnormal liver and kidney function test results
night sweats
itching, rash
hair loss
back pain, muscle or joint pain, muscle cramps
dizziness, weakness, or general malaise
Uncommon (may occur in no more than 1 in 100 people)
agitation
tremor
deafness
irregular heartbeat
urticaria, dry skin
presence of blood in urine
male infertility (see section "Fertility")
chest pain
Retinal detachment has been reported only in CMV-infected AIDS patients treated with valganciclovir.
Additional side effects in children and adolescents
Side effects in children and adolescents are similar to those observed in adult patients.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Side effects may also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ceglar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, cardboard box, or bottle after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Period of use after first opening the bottle: 2 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ceglar contains

• The active substance is valganciclovir (as valganciclovir hydrochloride). Each film-coated tablet contains 450 mg of valganciclovir (as valganciclovir hydrochloride).
• Other ingredients are:
  Tablet core: microcrystalline cellulose (PH101), crospovidone (type A), povidone (K-30), stearic acid 50.
  Coating: Opadry Pink 15B24005: hypromellose (3 cP), hypromellose (6 cP), titanium dioxide (E 171), polyethylene glycol 400, iron oxide red (E 172), polysorbate 80.

What Ceglar looks like and contents of the pack
Ceglar tablets are pink, oval, biconvex (16.7 x 7.8 mm), with the symbol
"J" debossed on one side and "156" on the other.
Film-coated tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, in a cardboard box,
or in HDPE bottles containing a cotton plug, with a PP screw cap with child-resistant closure and seal,
and placed in a cardboard box.
Blisters: 10, 30, 60, 90 and 120 film-coated tablets.
Bottle: 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Tel. +48 22 209 70 00

Manufacturer/Importer
Lek S.A.
ul. Domaniewska 50C
02-672 Warsaw, Poland

This medicinal product is authorised for sale in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: